Device for use in molecular diagnostics testing

ABSTRACT

A device for use in molecular diagnostics testing includes at least one reagent storage container, the reagent storage container being sealed; at least one opener for unsealing the reagent storage container; and an actuator. The actuator is coupled to at least one of the reagent storage container and the opener such that moving the actuator brings the reagent storage container and the opener together so that the opener unseals the reagent storage container, but inadvertently opening is prevented.

CROSS REFERENCE TO RELATED APPLICATION

This is a divisional of prior U.S. patent application Ser. No.14/669,224, filed Mar. 26, 2015, now U.S. Pat. No. 10,035,148, which isa continuation of prior U.S. patent application Ser. No. 13/003,010,filed Jan. 7, 2011, now U.S. Pat. No. 8,992,856, which is a nationalstage application under 35 U.S.C. § 371 of International applicationserial no. PCT/IB2009/053031 filed on Jul. 13, 2009, which claimspriority to European patent application serial no. EP 08160333.4, filedon Jul. 14, 2008 and European patent application serial no. EP08169800.3, filed on Nov. 24, 2008, which are each incorporated hereinby reference.

FIELD OF THE INVENTION

The invention relates to a device for use in molecular diagnosticstesting.

BACKGROUND OF THE INVENTION

In systems for molecular diagnostics reagents can be stored in acontainer, for instance inside a disposable system. To guarantee areasonable shelflife the container needs to have sufficient barrierproperties. This leads most often to hermetically closed containers thatfulfill the lifetime requirements but make it hard to access the storedreagents. An example of a molecular diagnostics system comprising areagent storage container is found in WO093939.

SUMMARY OF THE INVENTION

It is an object of the invention to provide a device for use inmolecular diagnostics testing in which a reagent can be stored in areagent storage container under sealed conditions prior to use and inwhich the reagent storage container can be unsealed when the reagent isneeded for testing. The device according to the invention comprises atleast one reagent storage container that is sealed prior to use. Thedevice further comprises at least one opener for unsealing the reagentstorage container when the stored reagent is needed for testing. Whenthe reagent is needed, an actuator is operated by a person using thedevice. The actuator is coupled to at least one of the reagent storagecontainer and the opener. As a result of operating the actuator, thereagent storage container and the opener are moved together. As aconsequence hereof, the opener can unseal the reagent storage container,for instance by piercing a foil sealing the reagent storage containerwith a pointed tip.

An embodiment of the device according to the invention is characterizedin that the actuator is part of a manifold selectively coupleable to areagent storage container for removing content from the reagentcontainer.

This embodiment has the advantage that sometimes devices for use inmolecular diagnostics testing already comprise a manifold to selectivelycouple to a reagent storage container. The operation of the manifold,for instance, to selectively couple to a reagent storage container maybe used to open one or more reagent container(s) in one go, makingoperation of such devices simpler. Once a connection to the selectedreagent storage container has been established, at least part of thecontents of the reagent storage container is taken out (for instance byusing a plunger comprised in the manifold). Next, the manifold isoperated to couple to a process chamber and contents taken from thereagent storage container is passed from the manifold into the processchamber (for instance by again using the aforementioned plunger). Atthat time, the process chamber comprises a sample to be processed, theprocessing requiring the presence of the added reagent. Selecting areagent storage container often involves rotating the manifold, or someother motion of the manifold.

This embodiment has the advantage that it uses motion of the manifold, afeature that is already present in some devices, for unsealing a reagentstorage container.

A further embodiment of the device according to the invention ischaracterized in that the actuator is rotatable.

This embodiment has the advantage that compact construction of thedevice is possible as the actuator can stay in a single location duringits operation.

A further embodiment of the device according to the invention ischaracterized in that the actuator is coupled to at least one of thereagent storage container and the opener using a cable that is pulled bymoving the actuator.

This embodiment has the advantage that a cable provides an easy andflexible means for coupling the actuator to at least one of the reagentstorage container and the opener. The flexibility offered by a cableenables that the actuator can be coupled to at least one of the reagentstorage container and the opener around bends and other obstacles.

A further embodiment of the device according to the invention ischaracterized in that the actuator is coupled to at least two reagentstorage containers and/or at least two openers using cables of differentlengths.

3 This embodiment has the advantage that it allows different reagentstorage containers to be unsealed at different times.

A further embodiment of the device according to the invention ischaracterized in that the actuator is coupled to at least one of thereagent storage container and the opener using an actuation plate, theactuation plate comprising a trajectory along which one of the reagentstorage container and the opener is moved towards the other of thereagent storage container and the opener.

This embodiment has the advantage that it provides an easy means formoving a reagent storage container and an opener towards each other,especially if multiple reagent storage containers need to be unsealed.Multiple reagent storage containers and/or multiple openers can be movedusing a single actuation plate.

A further embodiment of the device according to the invention ischaracterized in that the actuation plate comprises differenttrajectories for different reagent storage containers and/or differentopeners.

This embodiment has the advantage that different trajectories allowdifferent reagent storage containers and/or different openers to bemoved towards each other at different speeds, allowing different reagentstorage containers to be opened at different times.

A further embodiment of the device according to the invention ischaracterized in that the actuation plate further comprises a furthertrajectory intersecting a trajectory along which one of the reagentstorage container and the opener is moved towards the other of thereagent storage container and the opener at a point at which the reagentstorage container and the opener reach their final positions relative toeach other.

This embodiment has the advantage that it allows using the actuator aspart of a manifold.

A further embodiment of the device according to the invention ischaracterized in that the actuator is coupled to at least one of thereagent storage container and the opener using a rotationallyasymmetrical actuation ring, the actuation ring forcing at least one ofthe reagent storage container and the opener towards the other of thereagent storage container and the opener.

This embodiment has the advantage that it provides an easy means formoving a reagent storage container and an opener towards each other.

A further embodiment of the device according to the invention ischaracterized in that the actuation ring comprises a protrusion formoving one of the reagent storage container and the opener towards theother of the reagent storage container and the opener.

This embodiment has the advantage that easy means for moving a reagentstorage container and an opener towards each other.

A further embodiment of the device according to the invention ischaracterized in that the device comprises at least two actuation ringscoupled to different reagent storage containers and/or differentopeners.

This embodiment has the advantage that it allows the amount of motion ofthe actuator needed to unseal a reagent storage container to beindividualized for individual reagent storage containers.

A further embodiment of the device according to the invention ischaracterized in that the actuator comprises a thread for moving thereagent storage container and the opener towards each other.

This embodiment has the advantage that it provides an easy way formoving the reagent storage container and the opener towards each other,especially if the actuator is a rotatable manifold.

A further embodiment of the device according to the invention ischaracterized in that the actuator comprises a shaped ring, the shapedring comprising a non-flat shaped surface facing at least one of thereagent storage container and the opener for moving the reagent storagecontainer and the opener towards each other in the direction of the axisof rotation of the actuator.

This embodiment has the advantage that it provides an alternative to athread and, additionally, allows sequential opening of different reagentstorage containers depending on the exact shape of the non-flat shapedsurface. The steeper, for instance, undulations on the non-flat shapedsurface, the quicker a reagent storage container and an opener are movedtowards each other.

A further embodiment of the device according to the invention ischaracterized in that the device comprises locking means for temporarilypreventing the reagent storage container and the opener from movingtowards each other.

This embodiment has the advantage that it reduces the risk of unintendedopening of a reagent storage container. Obviously, it is not intended toopen a reagent storage container during storage of the reagent storagecontainer. Locking means can prevent unintended opening and afterunlocking or removal of the locking means, a reagent storage containercan be opened for use.

A further embodiment of the device according to the invention ischaracterized in that the device is a cartridge insertable into a devicefor molecular diagnostics testing. This embodiment has the advantagethat a cartridge insertable into a device for molecular diagnosticstesting is more flexible than a device for molecular diagnostics testinginto which a sample to be tested is inserted directly, that is withoutbeing inserted into a cartridge first. Moreover, a cartridge for a usein molecular diagnostics testing would benefit from any one of theprevious embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically shows a device according to the inventioncomprising an actuator that can be translated;

FIG. 2 schematically shows a further device according to the inventioncomprising a rotatable actuator coupled using a cable;

FIG. 3 schematically shows a further device according to the inventioncomprising an actuation plate;

FIG. 4 schematically shows a further device according to the inventioncomprising a rotationally asymmetrical actuation ring;

FIG. 5 schematically shows a further device according to the inventioncomprising a different rotationally asymmetrical actuation ring;

FIG. 6 schematically shows a cartridge according to the invention, thecartridge being insertable into a device for molecular diagnosticstesting;

FIG. 7 schematically shows a further device according to the inventionwherein the actuator comprises thread for moving a reagent storagecontainer and an opener together;

FIG. 8 schematically shows a further device according to the inventionwherein the actuator comprises a shaped ring comprising a shapedsurface.

DETAILED DESCRIPTION OF EMBODIMENTS

FIG. 1 schematically shows a device according to the inventioncomprising an actuator that can be translated. The present figure showsreagent storage containers 1, openers 5, and an actuator 10. The reagentstorage containers 1 and the openers 5 are movable towards each other,for instance, by mounting the reagent storage containers 1 and/or theopeners 5 on a rail like construction (not shown). The actuator 10 ismovable in a direction towards the openers 5 and 10, for instance, themanually operated by a person using the device in FIG. 1. Moving theactuator 10 towards the openers 5, the actuator 10 pushes the reagentstorage containers 1 towards the openers 5. As in all embodiments shownin this document, the openers 5 comprise means for unsealing the reagentstorage containers 1 such as, for instance, a pointed tip, a hollowneedle, etc. In the present embodiment, the tip pierces a seal on thereagent storage containers 1, after which reagents stored in the reagentstorage containers 1 can be removed from the reagent storage containers1. If the pointed tips comprise, for instance, hollow needles, removingreagents from the reagent storage containers 1 can be achieved bytransporting the reagents through the hollow needles and then onwardstowards the locations where the reagents are needed.

An alternative arrangement is shown using the dashed lines. Actuator 15is movable along the reagent storage containers 1 which, in thisparticular embodiment, have protrusions for core operating with theactuator 15. As the actuator 15 moves along the reagent storagecontainers 1 it pushes the reagent storage containers 1 towards theopeners 5. The protrusions allow the actuator 15 to push a specificreagent storage container 1 towards a corresponding opener 5 while, atthe same time, allowing the actuator 15 to continue on to the nextreagent storage container 1. The distance between a specific reagentstorage container 1 and its corresponding opener 5 on the one hand andthe dimensions of the actuator 15 and the protrusion only specificreagent storage container 1 on the other hand need to be chosen suchthat after the actuator 15 has passed a protrusion, the reagent storagecontainer 1 is moved close enough to its corresponding opener 5 that thereagent storage container 1 can be unsealed and its contents removed. Inthe present figure, the distance between the reagent storage containersand the corresponding openers 5 has been chosen too large for clarity.

Use of the actuator 15 has the advantage that the relative position of areagent storage container 1 and its corresponding opener 5 remainunchanged after the actuator 15 has passed a specific reagent storagecontainer 1. Once moved towards each other, the relative position of areagent storage container 1 and its corresponding opener 5 remainsunchanged. This has the advantage that the actuator 15 may be arrangedto form a manifold that can couple selectively to one of the reagentstorage containers 1. The manifold variant is indicated by thedashed/dotted addition to the actuator 15. Once moved along all thereagent storage containers 1, the actuator 15 (now acting as a manifold)can coupled to a specific opener 5 after which reagent can be removedfrom the reagent storage container 1 coupled to that specific opener 5.The reagent may be removed from the reagent storage container 1 using aplunger 18 integrated into the actuator 15. After reagent has beenremoved from a reagent storage container 1 the actuator 15 may becoupled to a process chamber (not shown) into which the removed reagentis inserted. Once in the process chamber, the reagent can be used formolecular diagnostics testing.

It will be clear to a person skilled in the art that the protrusionsneed not necessarily be located on the side of the reagent storagecontainers 1 that faces away from the openers 5. The protrusions may,for instance, also be positioned as the protrusions 55 in FIGS. 3-5.Moreover, one might even do without protrusions at all. What matters isthat the reagent storage containers 1 comprised a location on which anactuator can exert force and which allowed, if need be, an actuator tomove from one reagent storage container 1 to the next (as is the casewith the actuator 15, but not with the actuator 10). Furthermore, itwill be clear to a person skilled in the art that further variations onthe arrangement shown in FIG. 1 are possible as well. For instance, theactuator 10 (or, alternatively, the actuator 15) may be arranged to acton the openers 5 instead of on the reagent storage containers 1 formoving the reagent storage containers 1 and the openers 5 towards eachother.

FIG. 2 schematically shows a further device according to the inventioncomprising a rotatable actuator coupled using a cable. The presentfigure again shows reagent storage containers 1 and openers 5, just asin FIG. 1. However, in the present figure there is a rotatable actuator20. Similar to the actuator 10 and the actuator 15 shown in FIG. 1, theactuator 20 may be manually operated by a person operating the deviceshown in FIG. 2. The actuator 20 is coupled to the reagent storagecontainers 1 using cable 25 and bar 30. As the actuator 20 is rotatedcounter clockwise, the reagent storage containers 1 are pulled towardsthe openers 5. Again, just as in FIG. 1, the openers 5 comprise meansfor unsealing the reagent storage containers 1.

If the cable 25 is provided with enough slack, the actuator 20 mayrotate further (both clockwise and counter clockwise) within the limitsof the amount of slack provided after a reagent storage container 1 hasbeen unsealed by its corresponding opener 5 without affecting therelative position of the reagent storage container 1 and itscorresponding opener 5. Once moved towards each other, the relativeposition of a reagent storage container 1 and its corresponding opener 5remains unchanged. This has the advantage that the actuator 20 may bearranged to form a manifold that can couple selectively to one of thereagent storage containers 1. A rotatable actuator arranged to act asmanifold is shown in FIGS. 4 and 5. The difference between these twofigures and the present figure is that in the present figure theactuator 20 is coupled to the reagent storage containers 1 using a cable25 instead of the actuation ring 60 in FIG. 4 and the actuator ring 85in FIG. 5.

It will be clear to a person skilled in the art that variations to thearrangement shown in FIG. 2 are possible. For instance, the reagentstorage containers 1 and the openers 5 may exchange positions so thatthe actuator 20 exerts a force on the openers 5 instead of on thereagent storage containers 1. Another variation is that the reagentstorage containers 1, or in the previous variation the openers 5, arecoupled individually to the actuator 20 using individual cables. In thelatter of variation, cables of different lengths may be used fordifferent couplings. In this way, different reagent storage containers 1may be unsealed at different times by requiring the actuator 20 to berotated over different angles.

FIG. 3 schematically shows a further device according to the inventioncomprising an actuation plate. The present figure again shows reagentstorage containers 1 and openers 5, just as in FIG. 1. In the presentfigure in the reagent storage containers 1 comprise protrusions 55. Inthis particular embodiment, the protrusions 55 have been arranged on thesides of the reagent storage containers 1 facing away from the viewer.Consequently, the protrusions 55 have been indicated by dashed circles.In the present figure, the openers 5 are comprised in housing 35. Thehousing 35 houses a rotatable actuator 40. The actuator 40 is coupled tothe actuation plate 45. As the actuator 40 is rotated, the actuationplate 45 rotates with it. The actuation plate 45 comprises trajectoriesfor guiding the reagent storage containers 1 towards the openers 5. Thetrajectories have been schematically indicated by the dashed curves 50,53. The trajectories spiral towards the centre of the actuation plate45. The trajectories may comprise, for instance, a groove or a ridge.The reagent storage containers 1 are movable along straight linesrunning through the centre of the actuator 40. If the trajectoriescomprise grooves, the protrusions 55 enter their respective grooves andfollow the trajectories. Consequently, the reagent storage containers 1are moved towards the openers 5 as the actuator 40 and, consequently,the actuation plate 45 rotate counter clockwise. If the trajectoriescomprise ridges, the ridges contact the protrusions 55 on the sides ofthe protrusions 55 that face away from the centre of the actuator 40. Asthe actuator 40 and, consequently, the actuation plate 45 rotate counterclockwise, the protrusions 55 slide along the ridges moving the reagentstorage containers 1 towards the openers 5.

The actuation plate 45 can be adapted to allow further rotation (bothclockwise and counter clockwise) of the actuator 40 after the reagentstorage containers 1 have been unsealed by their respective openers 5.To this end, the actuator plate 45 comprises the dashed/dottedtrajectory. This latter trajectory intersects the points of the othertrajectories at which the reagent storage containers 1 reach their finalpositions relative to their respective openers 5. If the spiralingtrajectories comprise grooves, the dashed/dotted trajectory comprises acircular groove. Once the reagent storage containers 1 reach their finalpositions relative to their respective openers 5, the protrusions 55enter the dashed/dotted trajectory. The actuator 40 and, consequently,the actuation plate 45 can then rotate without affecting the positionsof the reagent storage containers 1 relative to their respective openers5. If the spiraling trajectories comprise ridges, the dashed/dottedtrajectories comprise an opening in or termination of the ridges. Oncethe reagent storage containers 1 reach their final positions relative totheir respective openers 5, the protrusions 55 enter the dashed/dottedtrajectory. Rotation of the actuator 40 and, consequently, of theactuation plate 45 then no longer affects the positions of the reagentstorage containers 1 relative to their respective openers 5. Thedashed/dotted trajectory allows the housing 35 and the actuator 40 to beadapted to function as a manifold. The manifold can selectively coupleto one of the reagent storage containers 1 to remove reagent from thatreagent storage container 1. Removal may take place using, for instance,a plunger integrated into the manifold. After removal of the reagent,the manifold can be coupled to a process chamber in which the reagent isused during testing. Adapting the housing 35 in the actuator 40 tofunction as a manifold is further discussed in relation to FIG. 4.

It will be clear to a person skilled in the art that variations on thearrangement shown in FIG. 3 are possible. For instance, the positions ofthe reagent storage containers 1 and the openers 5 may be reversed. Inanother variation, the openers 5 may be arranged to move outwards fromthe centre of the actuator 40 along trajectories that spiral outwardsinstead of inwards. In a combination of the previous two variations,reagent storage containers 1 may be arranged to move outwards alongoutwardly spiraling trajectories towards the openers 5. With a reagentstorage container 1 or an opener 5 moving outwards from the centre ofthe actuator 40 along a trajectory comprising a ridge, the ridgecontacts the protrusion 55 on the side of the protrusion 55 facing thecentre of the actuator 40. In another variation, the curvature of thetrajectories is chosen to define the angle through which the actuator 40must rotate to bring a reagent storage container 1 and its correspondingopener 5 together. The amount of curvature may be different fordifferent trajectories.

FIG. 4 schematically shows a further device according to the inventioncomprising a rotationally asymmetrical actuation ring. The presentfigure again shows reagent storage containers 1, openers 5, housing 35,rotatable actuator 40, and protrusions 55 just as in FIG. 3. The reagentstorage containers 1 are movable along straight lines through the centreof the actuator 40. However, in the present figure in the actuator 40 iscoupled to actuation ring 60. As the actuator 40 rotates, the actuationring 60 rotates with it. The actuation ring 60 comprises an actuationprotrusion 65. As the actuation protrusion 65 passes a protrusion 55during rotation of the actuation ring 60, the reagent storage container1 coupled to that protrusion 55 is moved towards its correspondingopener 5. The distance between a protrusion 55 of a specific reagentstorage container 1 and its corresponding opener 5 on the one hand andthe dimensions of the actuation protrusion 65 need to be chosen suchthat after the actuation protrusion 65 has passed the protrusion 55, thereagent storage container 1 is moved close enough to its correspondingopener 5 that the reagent storage container 1 can be unsealed and itscontents removed. In the present figure, the distance between theprotrusions 55 and the corresponding openers 5 has been chosen too largefor clarity.

The actuation ring 60 and its co-operation with the protrusions 55 havethe advantage that the relative position of a reagent storage container1 and its corresponding opener 5 remain unchanged if the actuator 40and, consequently, the actuation ring 60 rotate further, after theactuation protrusion 65 has passed a specific protrusion 55. Once movedtowards the centre of the actuator 40, a reagent storage container 1remains in that position. This has the advantage that the housing 35 andthe actuator 40 may be arranged to form a manifold that can coupleselectively to one of the reagent storage containers 1. After rotatingthe actuator 40 and, consequently, the actuation ring 60 through anangle large enough to unseal a reagent storage container 1, the actuator40 can rotate to couple the channel 70 to the unsealed reagent storagecontainer. Next, at least part of the contents of the unsealed reagentstorage container can be removed from that reagent storage containerusing, for instance, a plunger integrated into the manifold. The plungermay be positioned, for instance, perpendicularly to the plane of thedrawing and be integrated into the actuator 40. After reagent has beenremoved from the unsealed reagent storage container, the actuator 40rotates once more to couple the channel 70 to the further channel 75(now indicated by the dashed channel) coupled to a process chamber 80.Once the channel 70 has been coupled to the further channel 75, theplunger integrated into the actuator 40 may again be used to injectreagent removed from the unsealed reagent storage container into thefurther channel 75 and from there into the process chamber 80. Insidethe process chamber 80, the reagent may be used, for instance, inmolecular diagnostics testing.

It will be clear to a person skilled in the art that variations to thearrangement shown in the present figure are possible. In one variation,the actuation ring 60 comprises at least two actuation protrusions 65.With more than one actuation protrusion 65 the angle through which theactuator 40 must rotate before a reagent storage container 1 is unsealedbecome smaller than with only one actuation protrusion 65. In a furthervariation the number of reagent storage containers 1 and openers 5different from the two reagent storage containers 1 and openers 5 shownin FIG. 4. In yet a further variation, an actuation ring having anactuation protrusion that faces away from the centre of the actuator 40instead of towards the centre of the actuator 40 as in the presentfigure may be used to move the openers 5 outwards towards the reagentstorage containers 1. In these variations care needs to be taken toensure that channel couplings are such that reagent can be removed froman unsealed reagent storage container. Usually, this will mean that achannel for removing reagent from a reagent storage container must beable to be coupled to an opener. Consequently, a further embodimentcomprises an actuator coupled to an actuation ring comprising an outwardfacing actuation protrusion and at least one reagent storage containerarranged around the actuation ring. The reagent storage containers facecorresponding openers arranged along a larger circle concentric with thecircle of the actuation ring. Each opener is coupled to a channel whichin turn is coupled to a manifold. As the actuation ring rotates, thereagent storage containers are moved towards their correspondingopeners. Once unsealed, reagent can be removed from the reagent storagecontainers using, for instance, a plunger integrated into the manifold.The manifold can selectively couple to one of the openers and to aprocess chamber into which reagent removed from a reagent storagecontainer can be inserted. In this embodiment, the manifold and theactuator are not integrated.

FIG. 5 schematically shows a further device according to the inventioncomprising a different rotationally asymmetrical actuation ring. Thepresent figure again shows reagent storage containers 1, openers 5, ahousing 35, an actuator 40, and protrusions 55, just as in FIG. 4.Again, the reagent storage containers 1 are movable along straight linesthrough the centre of the actuator 40. Just as in FIG. 4, thearrangement of the present figure may comprise a channel 70, a furtherchannel 75, and a process chamber 80. However, for reasons ofsimplicity, these elements are not shown in the present figure. Thepresent figure shows a further embodiment of a rotationally asymmetricactuation ring. In the present figure, the actuation ring 85 has anelliptical shape. Again, the actuation ring 85 is coupled to theactuator 40. As the actuator 40 rotates, the actuation ring 85 rotateswith it. Before unsealing, the reagent storage containers 1 arepositioned towards the longer axis of the ellipse shaped actuation ring85. As the actuator 40 and, consequently, the actuation ring 85 rotatethe centre facing side of the actuator ring 85 starts pushing againstthe protrusions 55. As a result, the reagent storage containers 1,movable along straight lines through the centre of the actuator 40,moved towards their respective openers 5. The length of the shorter axisof the ellipse shaped actuation ring 85 has been chosen such that thereagent storage containers 1 can be unsealed by their respective openers5 as the shorter axis nears the reagent storage containers 1 (indicatedby the dashed actuation ring 85 and the dashed reagent storage container1). Once unsealed, reagent can be removed from the reagent storagecontainers 1, for instance, in the way shown in FIG. 4.

The ellipse shaped actuation ring 85 and the cooperating protrusions 55have the advantage that the relative position of a reagent storagecontainer 1 and its corresponding opener 5 remain unchanged if theactuator 40 and, consequently, the actuation ring 85 rotate further,after the shorter axis has passed a specific protrusion 55. Once movedtowards the centre of the actuator 40, a reagent storage container 1remains in that position. This has the advantage that the housing 35 andthe actuator 40 may be arranged to form a manifold that can coupleselectively to one of the reagent storage containers 1. Such a manifoldhas already been discussed in relation to FIG. 4.

It will be clear to a person skilled in the art that variations on thearrangement shown in the present figure are possible. In the presentfigure protrusions inside the ellipse shaped actuation ring 85 are movedtowards the centre of the ellipse. Alternatively, an ellipse shapedactuation ring may be used to move a reagent storage container or anopener outwards away from the centre of the ellipse. One embodiment ofsuch an arrangement comprises an ellipse shaped actuation ring coupledto an actuator. This embodiment further comprises a reagent storagecontainer positioned near the shorter axis of the ellipse prior tounsealing of the reagent storage container and a corresponding openerfacing the sealed portion of the reagent storage container. As theactuator and, consequently, the actuation ring rotate, the reagentstorage container moves outwards from the centre of the ellipse as thelonger axis of the ellipse nears the reagent storage container. Thedistance between the reagent storage container and the opener are chosensuch that the opener can unsealed the reagent storage container as thelonger axis of the ellipse shaped actuation ring nears the position ofthe reagent storage container.

FIG. 6 schematically shows a cartridge according to the invention, thecartridge being insertable into a device for molecular diagnosticstesting. The present figure shows a cartridge 90 insertable into adevice for molecular diagnostics testing 95. The device for moleculardiagnostics testing 95 comprises means for processing the cartridge 90such as, for instance, heaters and coolers (for instance for use innucleic acid amplification) and detection means for detecting signalsfrom a sample that is tested. The cartridge 90 comprises a reagentstorage container, an opener, and an actuator according to any one ofthe embodiments of the present invention. Insertion of the cartridge 90into the device for molecular diagnostics testing 95 is indicated by thearrow.

FIG. 7 schematically shows a further device according to the inventionwherein an actuator 700 comprises thread 705 for moving a reagentstorage container 710 and an opener 715 together. Turning of theactuator 700, which also functions as a manifold, moves the reagentstorage container 710 and the opener 715 towards each other so that thereagent storage container is unsealed by the opener and reagent can beremoved from the reagent storage container. The reagent storagecontainer 710 and the opener 715 and move towards each other because atleast one of them is connected to a thread cooperating with the threadon the actuator 700. In the present embodiment it is the reagent storagecontainer 710 that is connected to thread that co-operates with thethread of the actuator 700. The reagent storage container 710 isprevented from rotating itself by ribs 720. The ribs 720 are kept inplace by cooperating ribs or grooves in the housing in which the deviceshown in the present figure is placed. The housing is not shown in FIG.7. It will be clear to a person skilled in the art that numerous otheroptions exist to prevent the reagent storage container 710 (or,alternatively, the opener 715) from rotating. In the present example,the reagent storage container 710 moves towards the opener 715 if theactuator 700 is turned in the proper direction. The opener 715 comprisesmeans 725 for unsealing the reagent storage container 710. The means 725may comprise, for instance, a pointed tip, a hollow needle, etc. for,for instance, piercing a foil sealing the reagent storage container 710on the side facing the opener 715. The reagent storage container 710 maycomprise one or more storage compartments 730 for storing differentreagents. Similarly, the opener 715 may comprise one or more means 725for unsealing the reagent storage container 710 coupled to openercompartments 735, so that the various storage compartments 730 in thereagent storage container 710 can be unsealed individually. The actuator700 comprises one or more openings 740 selectively coupling to one ormore opener compartments 735. Through such an opening 740 reagent can beremoved from a storage compartment 730 comprised in the reagent storagecontainer 710 via the means 725 and an opener compartment 735 forinstance by operating a plunger (not shown) inside the actuator 700.

FIG. 8 schematically shows a further device according to the inventionwherein the actuator 800 comprises a shaped ring 805 comprising a shapedsurface 810. The shaped surface 810 comprises one or more ‘hills’ 815and ‘troughs’ 820. The actuator 800 is positioned such that the shapedsurface 810 with the hills 815 and troughs 820 faces at least one of areagent storage container 825 and an opener 830. In the present figure,the shaped 805 ring faces two reagent storage containers 825. Initially,the reagent storage containers 825 are aligned with troughs 820. Turningof the shaped ring 805 then aligns the reagent storage containers 825with hills 815. As the points of contact between the reagent storagecontainers 825 and the shaped ring 805 move closer to the crest of ahill 815, the reagent storage containers 825 are pushed towards theopener 830. The reagent storage containers 825 are supported such thatthey can only move along the line indicated by the arrow 890 (supportnot shown, but, for instance, a pin/groove support would be suitable).The height of the crest of a hill 815 is such that, at least when thecontact point between a reagent storage container 825 and the shapedring 805 reaches the crest, the reagent storage container 825 is movedover a distance sufficient to have the reagent storage container 825opened by the opener 830. To this end, the opener 830 comprises one ormore means 835 for unsealing one or more reagent storage containers 825.Examples of such means 835 pointed tips, hollow needles, etc. the opener830 comprises compartments 840 coupled to the means 835. The differentcompartments 840 may be regarded as separate openers 830. Consequently,separate, mutually disconnected, openers may be used instead of a singleopener 830 comprising multiple compartments 840 as shown in the presentfigure. A reagent storage container 825 may be supported by a supportelement 845, for instance a resilient element such as a spring, toprevent the reagent storage container 825 from being opened by theopener 830 prior to use of the shaped ring 805 with respect to thereagent storage container 825. As shown in the present figure, theshaped ring 805 may comprise a plurality of hills 815 and troughs 820 tosimultaneously support the opening of a plurality of reagent storagecontainers 825. The amplitudes of the various hills 815 and troughs 820may be different to allow the sequential opening of different reagentstorage containers 825 or to allow more freedom in the positioning ofreagent storage containers 825 and their respective means 835 forunsealing (the reagent storage containers 825 and, similarly, theirmeans 835 for unsealing need not lie in a single plane perpendicular tothe direction of motion of a reagent storage container 825 and a means835 for unsealing towards each other. The actuator 800 comprises atleast one opening 850 for selectively coupling to a compartment 840 inthe opener 830. After unsealing of a reagent storage container 825,reagent may be withdrawn from this reagent storage container 825 via themeans 835 and the compartment 840 and the opening 850, for instance, byoperating a plunger inside the actuator 800 (plunger not shown).

Clearly, the arrangement of the present figure can also be reversed withthe shaped ring 805 moving an opener 830 towards a reagent storagecontainer 825 instead of the other way round as in the present figure.The alternative arrangement simply requires the reagent storagecontainer 825 and the opener a camera 830 to swap places as compared tothe arrangement in the present figure.

The present figure also shows a locking means 855 for preventing areagent storage container 825 from being inadvertently opened by itsmeans 835 for unsealing, for instance during storage of the device.Although it is shown in the present figure, a locking means 855 may beincorporated into any of the embodiments shown in the presentapplication. After all, preventing inadvertent opening would benefit anyembodiment. As will be evident to a person skilled in the art, variouslocking means are possible such as pin and hole/groove arrangements. Inthe present figure, the means 855 comprise a protrusion that issupported in the housing comprising the actuator 800 over a limitedangle of rotation. The housing is only partially shown and the part ofthe housing supporting the locking means 855 is indicated by the dashedpart 860. Once the actuator 800 is rotated over an angle exceeding theangle of rotation over which the protrusion 855 is supported by thehousing, the shaped ring 805 is allowed close enough to the reagentstorage containers 825 for them to be opened. This latter situation isthe situation depicted in FIG. 8. The movement from the locking means855 from the situation in which it is supported by the dashed part ofthe housing to the situation in which the locking means 855 are nolonger supported is indicated by the arrow 870.

An alternative or additional locking means comprises a groove 880 on theactuator 800 that holds a pin 885 comprised the housing of the actuator800. Again, these locking means may be combined with any of the previousembodiments of the present invention. For instance during storage of thedevice shown in FIG. 8, the pin 885 rests in the part of the groove 880indicated as 880A. With the pin 885 in that position, the actuator 800is prevented from rotating so that it is unable to move a reagentstorage container 825 and its opener 830 towards each other. By movingthe actuator 800 slightly in the direction indicated by the arrow 890,the pin 885 is able to enter the part of the groove 880 indicated as880B and that extends in the direction of rotation of the actuator 800.Once the pin 885 is in the groove 880B, the actuator 800 is allowed torotate so that its shaped surface 805 can interact with a reagentstorage container 825 (or an opener 830) to move the reagent storagecontainer 825 and its opener 830 towards each other. Clearly, theposition of the grooves 880A and 880B and the pin 885 may be reversed inthat the grooves 880A and 880B may be comprised in the housing holdingthe actuator 800 instead of in the actuator 800 itself and in that thepin 885 may be comprised in the actuator 800. It will also be clear thatthe grooves 880A and 880B may be repositioned relative to each othersuch that instead of by moving the actuator 800 in the directionindicated by the arrow 890, the actuator 800 is released by moving theactuator 800 in the opposite direction.

It should be noted that the above-mentioned embodiments illustraterather than limit the invention, and that those skilled in the art willbe able to design many alternative embodiments without departing fromthe scope of the appended claims. In the claims, any reference signsplaced between parentheses shall not be construed as limiting the claim.The word “comprising” does not exclude the presence of elements or stepsother than those listed in a claim. The word “a” or “an” preceding anelement does not exclude the presence of a plurality of such elements.In the system claims enumerating several means, several of these meanscan be embodied by one and the same item of computer readable softwareor hardware. The mere fact that certain measures are recited in mutuallydifferent dependent claims does not indicate that a combination of thesemeasures cannot be used to advantage.

The invention claimed is:
 1. A device for use in molecular diagnosticstesting comprising: a sealed reagent storage container; an openerconfigured to unseal the sealed reagent storage container; a housing;and an actuator located in the housing and coupled to at least one ofthe sealed reagent storage container and the opener, the actuator beingconfigured to move from a locked position to an unlocked position tobring the sealed reagent storage container and the opener together, andthe opener being configured to unseal the sealed reagent storagecontainer in response to a movement of the actuator, wherein theactuator includes a locking protrusion for being supported on a part ofthe housing, wherein, in the locked position, the locking protrusion isconfigured to prevent movement of the sealed reagent storage containerand the opener towards each other, and wherein, in the unlockedposition, the locking protrusion is configured to allow the movement ofthe sealed reagent storage container and the opener towards each other.2. The device of claim 1, wherein the locking protrusion is configuredto rest on a ridge of the part of the housing.
 3. A device for use inmolecular diagnostics testing comprising: a sealed reagent storagecontainer; an opener configured to unseal the sealed reagent storagecontainer; a cartridge configured to be insertable into a device formolecular diagnostics testing; a housing located in the cartridge; andan actuator located in the housing and coupled to at least one of thesealed reagent storage container and the opener, the actuator beingconfigured to bring the sealed reagent storage container and the openertogether, and the opener being configured to unseal the reagent storagecontainer in response to a movement of the actuator, wherein one of theactuator and the housing includes a groove, and another of the actuatorand the housing includes a locking protrusion configured to rest in thegroove in a locked position to prevent movement of the sealed reagentstorage container and the opener towards each other in the lockedposition.
 4. The device of claim 3, wherein the locking protrusion isconfigured to not rest in the groove in the unlocked position.
 5. Adevice for use in molecular diagnostics testing comprising: a sealedreagent storage container; an opener configured to unseal the sealedreagent storage container; a housing; and an actuator located in thehousing and coupled to at least one of the sealed reagent storagecontainer and the opener, the actuator being configured to move from alocked position to an unlocked position to bring the sealed reagentstorage container and the opener together, and the opener beingconfigured to unseal the sealed reagent storage container in response toa movement of the actuator, wherein one of the actuator and the housingincludes a groove, and another of the actuator and the housing includesa locking protrusion, wherein the locking protrusion is configured toprevent movement of the sealed reagent storage container and the openertowards each other in the locked position when the locking protrusion islocated in the groove, and wherein the locking protrusion is configuredto allow the movement of the sealed reagent storage container and theopener towards each other in the unlocked position when the lockingprotrusion is not located in a first part of the groove.
 6. The deviceof claim 5, wherein the locking protrusion rests in a second part of thegroove in the unlocked position, and wherein the actuator includes anactuator protrusion for being supported on a part of the housing.
 7. Asystem comprising the device of claim 5, the system further comprising:a cartridge, wherein the housing is located in the cartridge; and atesting device having an opening, wherein the cartridge is configured tobe insertable into the opening of the testing device.